Kornimate/medical-research-clean huggingface dataset:
cardiobbeat - randomized controled trial to evaluate the health economic impact of remote patient monitoring

Conditions: Chronic Heart Failure

Summary: the primary endpoint is the incremental cost effectiveness ratio (icer), defined as the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost compared to that of the control group.

between january 2010 and june 2013, 621 patients with left ventricular ejection fraction (lvef) ≤ 40% were enrolled and randomly assigned to two study arms comprising usual care and a home telemonitoring group. the 302 patients enrolled in the intervention group are supported by an interactive bi-directional home telemonitoring system (motiva®) that collects and transfers patient's vital sign data to a dedicated telemedicine data centre. all patients were to remain in the study for one year with an examination at the beginning and both, after 6 and 12 months.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of chronic heart failure (chf) based on european society of cardiology (esc) guidelines * symptoms corresponding to new york heart association (nyha) functional class ii-iv * left ventricular ejection fraction (lvef) ≤ 40% * american heart association (aha) classification stage c or d * age \> 18 years * discharged after hospitalisation for worsening chronic heart failure (chf) within the last twelve months * able to understand the german language * sufficient eyesight to understand and follow the instructions communicated by the motiva® platform * willing and able to use the required hard- and software and maintain a patient diary * residing within geographical reach of one of the ten study sites in order to receive additional treatment if required as well as follow-up consultation * willingness to provide informed consent regarding benefits and risks related to the trial, and to sign a participation agreement for the installation of the telemedicine platform motiva® exclusion criteria: * myocardial infarction within the past four weeks * heart surgery or any coronary intervention within the past eight weeks * cardiogenic shock within the past four weeks * intended cardiac surgery within the next six months or priority status on a waiting list for organ transplantation * severe chronic and pulmonary illness with an immediate impact on the main outcome measures * renal failure requiring dialysis * dementia or other severe cognitive impairment * psychiatric disorders rendering patients unable to participate in the trial * discharged to or living in a geriatric clinic or a nursing home * participation in another clinical trial

Keywords: home telemonitoring
brief behavioral therapy for insomnia (bbt-i) for depressed outpatients with refractory insomnia

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to examine the effectiveness of brief behavioral therapy for insomnia (bbt-i) in addition to treatment as usual (tau) in comparison with tau alone for refractory insomnia among patients with major depression in partial remission.


Eligibility criteria:
inclusion criteria: 1. dsm-iv major depressive disorder, as ascertained by the structured clinical interview for dsm-iv axis i disorders (scid) 2. either sex, between 20 and 70 years of age at the time of entry into the trial 3. outpatient at the time of entry into the trial 4. for the index episode, patients have to have already been on two types of adequate doses of antidepressants for no shorter than 4 weeks for each medication or already on two types of antidepressants for 8 weeks in total even if the doses of the drugs have not been adequate due to side effects. the medication has not been changed for at least 4 weeks prior to the study entry. 5. a score of 2 on at least one of the three sleep items of the 17-grid-hamd and a score of 8 or more on the isi. 6. a score between 8 and 23 on the 17-grid-hamd. 7. agreement to the requirements that i) no change of medication will be allowed during the first 4 weeks of their study period, and ii) all the treatment sessions both of bbt-i and of tau will be audiotaped for the purpose of checking their adherence to the protocol exclusion criteria: 1. their mental or physical status at the time of entry into the trial is regarded as so critical as to need immediate hospitalisation 2. a serious suicidal risk, defined as a score of 3 or more on item 3 (suicidal ideation) of the 17-grid-hamd 3. patients who have had or are having any structured psychotherapy (e.g. cognitive therapy, or family therapy) at the time of entry 4. patients with current diagnosis of primary anxiety or personality disorder, insomnia associated with another sleep disorder, significant medical problems, current drug or alcohol substance abuse or dependence, or psychosis, or with a history of schizophrenia or bipolar disorder 5. patients with duration of depression shorter than 2 months 6. their insomnia is considered to derive from sleep apnoea or periodic limb movements during sleep, judged by their clinicians. 7. patients who engage in work involving night-shift, which might influence sleep status 8. patients currently taking methylphenidate or modafinil.

Keywords: depressive disorder sleep initiation and maintenance disorder behavior therapy
usefulness of high resolution manometry in constipation

Conditions: Constipation

Summary: constipation is a frequent symptom that is reported by more than 10% of the general population. in a few case, constipation is resistant to medical standard care, including osmotic and stimulant laxatives. the diagnosis of colonic inertia may be suspected in these patients although diagnostic criteria for colonic inertia may vary from one country to another. in france, the diagnosis of colonic inertia is based on manometric study of the colorectal contractile activity using manometric probe. using conventional manometric catheters, severe alteration of the colorectal motility is found in a very small subset of patients, who may later benefit from surgery. the recent use of high resolution manometric probe allowed to map more precisely colorectal motility, but whether these new parameters are relevant remains to be assessed. the aim of this study is to assess the diagnostic performance of a new high resolution manometric probe by comparing healthy volunteers to patients suspected of colonic inertia.


Eligibility criteria:
for patient inclusion criteria: * age between 18 and 65 years * chronic constipation (\> 6 months) * delayed colonic transit time \> 100 h * normal colonoscopy * constipation refractory to at least 1 osmotic and 1 stimulant laxative according french guidelines on constipation ; * affiliated to french national healthcare insurance exclusion criteria: * patient with constipation being either: * with colonic transit time \<100h * distal (with radio-opaque markers stasis in the rectum) * from organic origin * recent (\<6 mois) * relieved using osmotic or stimulant laxatives * contra-indication to the use of high resolution manometry insertion * intestinal occlusion * coagulation disorders, including anti-coagulant treatments * general anesthesia contra-indication * colonoscopy contra-indication * failure to perform a colonoscopy in previous attempts * medication intake that may impair colorectal motility, including opioids * evolutive inflammatory of neoplasia process * history of major digestive surgery (at exclusion of appendicectomy, cholecystectomy) * presence of condition that may impact digestive motility, including diabetes mellitus and sclerodermia * cardiologic disease that may represent a contraindication to vagal stimulation for healthy volunteers inclusion criteria: * age between 18 and 65 years * affiliated to french national healthcare insurance exclusion criteria: * significant digestive evolutive disease * constipation with kess score \> 11/39 and colonic transit time ≥ 60 h * contra-indication to the use of high resolution manometry insertion * intestinal occlusion * cardiac disease * coagulation disorders, including anti-coagulant treatments * general anesthesia contra-indication * colonoscopy contra-indication * history of major digestive surgery (at exclusion of appendicectomy, cholecystectomy) * presence of condition that may impact digestive motility, including diabetes mellitus and sclerodermia

Keywords: high resolution manometry
intravitreal bevacizumab for proliferative diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: recently, intravitreal bevacizumab (avastin) injection has gained popularity as a potential treatment of intraocular neovascularization (cnv) associated with age related macular degeneration and diabetic retinopathy. the efficacy of the drug is thought to be related with its pharmacologic blockade of vegf. the purpose of this study is to determine the effect of the intravitreal bevacizumab on the fibrovascular membrane associated with proliferative diabetic retinopathy by objective histologic evaluation. the patients scheduled for vitrectomy for tractional fibrovascular membrane due to proliferative diabetic retinopathy will be randomized into two treatment groups. the one will receive conventional vitrectomy and the other group will receive intravitreal bevacizumab injection one week before the scheduled vitrectomy. the fibrovascular membrane will be excised during surgery and fixated for histologic examinations. the expression of vegf and pedf, a potent inhibitor of angiogenesis, will be evaluated in the fibrovascular membrane by immunohistochemistry. the results will be compared between two treatment groups.


Eligibility criteria:
inclusion criteria: * tractional retinal detachment recently involving the macula with fibrovascular membrane due to proliferative diabetic retinopathy * severe fibrovascular proliferation progressing after appropriate panretinal photocoagulation exclusion criteria: * uncontrolled systemic hypertension * recent history of myocardiac infarction within 6 months * recent history of cerebrovascular accident within 6 months

Keywords: intravitreal bevacizumab proliferative diabetic retinopathy vegf pedf
abcsg 8 - adjuvant treatment in patients with hormone receptor-positive breast cancer with good to moderate differentiation.

Conditions: Breast Cancer

Summary: the purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.


Eligibility criteria:
inclusion criteria: * invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy. * at least 6 lymph nodes examined. * good or intermediate tumour differentiation. * \<6 weeks before start of adjuvant therapy. * oestrogen or progesterone positive exclusion criteria: * premenopausal. * preoperative hormonal/antihormonal/radiation/cytoxic chemo. second malignant tumour/status post second malignant tumour. * in-situ/t4 carcinoma. * age \>80 years. * world health organisation performance index \>3. * serious accompanying diseases
withings study to analyse the accuracy of screening small fiver neuropathy with a bathroom scale

Conditions: Neuropathy

Summary: the aim of this study is to evaluate the diagnostic performance of withings wbs08 to screen small fiber neuropathy.

patients with neuropathy are included in hospitals. each patient will have his neuropathy evaluated with withings wbs08 and its reference the sudoscan.

Eligibility criteria:
inclusion criteria: * the subject is an adult, man or woman (18 years old or more) * subjects affiliated or eligible to a social security system * subjects having expressed their consent to take part in the study * two type of patients are included in the study : * patients having diabetes (80% of the inclusion) * non diabetic patients having a lower limbs neuropathy (20% of the inclusion) exclusion criteria: * minors under 18 years old * subject is pregnant or trying to get pregnant * subjects having a pacemaker * subjects having refused to give their consent * vulnerable subjects according to the french regulation in force: * individuals deprived of liberty by a court, medical or administrative order * individuals legally protected or unable to express their consent to take part in the study * individuals unaffiliated to or not beneficiary of a social security system * individuals who fit in multiple categories above * individuals linguistically or mentally unable to express their consent * individuals having an lower limb amputation bigger than toes * individuals not able to stand still for a few minutes * individuals under antidepressant medications
rct for intermittent versus continuous propofol sedation for pediatric brain and spine mri studies

Conditions: Encephalopathy; Developmental Delay and Behavioral Changes; Cord Tumor Compression or Instability; Cord Tethering or Malformation

Summary: rct for intermittent versus continuous propofol sedation for pediatric brain and spine mri studies

a study comparing the dose of propofol used as a continuous infusion versus intermittent bolus dosing looking at recovery time complications, and quality of the mri studies in pediatric sedation services for patients age 1 month to 18 years receiving an brain or spine mri.

Eligibility criteria:
inclusion criteria: * age 1 month to 18 years * receiving a brain or spine mri with propofol sedation * deemed safe to undergo sedation with propofol based on a pre-sedation examination * patient judged not to require any pre-medication with any other medication except nasal decongestants or anticholinergic medications exclusion criteria: * patient below or above set age limits. * patient requires mri studies on other body areas. * patient requires pre-medication with a sedative or tranquilizer * patient requires additional medications during sedation to complete the procedure. * propofol is being used as a rescue sedative to complete the procedure. * propofol is being used as a rescue sedative to complete a procedure that was initiated by another sedative. * patients who develop complications that require termination of the imaging procedure will not be included in the dose or recovery time calculations, but the complication will be counted as such in their respective group and study will be reported as non-diagnostic. * insulin dependent diabetes * thyroid disease

Keywords: sedation mri pediatric propofol brain spine quality of mri continuous propofol dosing continuous propofol administration intermittent propofol dosing intermittent propofol administration sedative agent propofol continuous infusions recovery time complications of sedation bolus dosing
a descriptive study on patients with bipolar disorder in rwanda

Conditions: Mental Disorder; Bipolar Disorder

Summary: the aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in rwanda

the aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in rwanda for patients with bipolar disorder. knowing about the barriers to treatment, risk and protective factors as well as the current treatment offered for patients with bipolar disorder is essential for the development of therapeutic approaches and improvement in access to care. up to now, no data on characteristics of patients with bipolar disorder in rwanda and related risk and protective factors is available. for this purpose, all outpatients with bipolar disorder in rwanda age \> 18 years, will over a 1-year period be invited to participate in a survey on their experience living with bipolar disorder in rwanda. moreover, patients and relatives will be invited for in-depth interviews to explore their perceptions and experiences with the mental health system. health care providers will meet for focus discussions on to assess the experience, knowledge and practice of caregiving for individuals with bipolar disorder.

Eligibility criteria:
inclusion criteria: * a diagnosis of bipolar disorder type i or ii that meets dsm-v diagnostic criteria * age ≥ 18 years exclusion criteria: * none
amodiaquine plus artesunate versus lapdap plus artesunate in the treatment of uncomplicated p. falciparum malaria in malawi

Conditions: Malaria, Falciparum

Summary: sulfadoxine-pyrimethamine is the current first-line therapy for uncomplicated malaria in malawi. significant resistance of the p. falciparum malaria parasite to this drug has led to an imminent need for the government of malawi to identify a new first-line therapy for uncomplicated malaria and to implement that new therapy as policy. this protocol is the second of two protocols whose combined purpose is to provide efficacy and side effect data on four antimalarial drug combinations that are candidates for the next first-line therapy for uncomplicated malaria in malawi. this protocol aims to assess the acceptability and tolerability of amodiaquine in malawi. it is a double-blind study comparing amodiaquine plus artesunate (aq-art, one of the candidate combination therapies) to chlorproguanil/dapsone plus artesunate (cd-art, another of the candidate combination therapies) in persons 5 years and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the therapy in the aq-art group. amodiaquine was removed from the malawian national drug registry in 1995 because of a perceived association with abdominal pain. although no studies were conducted to substantiate this, consensus among clinicians was that patients were refusing amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was removed from the registry. results from this study, along with the efficacy data from the sister protocol in children under five years of age, will help guide the national malaria control program of malawi in selecting their next first-line antimalarial therapy.


Eligibility criteria:
inclusion criteria: * age five years or older * axillary temperature \>= 37.5 degrees celsius * monoinfection with p. falciparum * parasitemia between 2000 and 200000 parasites/microliter * hemoglobin concentration \>= 7g/dl * consent by the patient of patient's adult guardian * residence in the locality and willingness to attend for scheduled visits * negative urine pregnancy test in women age twelve years and older exclusion criteria: * signs of severe or complicated malaria * altered consciousness * convulsions * prostration (inability to sit/stand/suck/drink) * respiratory distress or breathlessness * jaundice * abnormal breathing * hemoglobinuria * circulatory collapse * persistent vomiting (cannot keep down liquids) * evidence of a diagnosis other than malaria on physical examination * presence of mixed infection * presence of severe malnutrition (as evidenced by symmetrical edema involving at least the feet, light hair color, or cachexia) * contraindications to the antimalarial drugs used, especially history of allergy * history of receiving a drug with antimalarial activity in the week prior to enrollment

Keywords: malaria, falciparum antimalarials
cardioprotective effects of increased endogenous erythropoietin after normobaric oxygen breathing

Conditions: Healthy; Coronary Artery Bypass Graft

Summary: tissue hypoxia is the only accepted trigger for erythropoietin (epo) production. however, in healthy subjects epo concentrations have also increased after oxygen breathing. the aim of our study is to confirm these observations. besides its main function in erythropoiesis, epo has also shown tissue protective effects. the second goal of our study is to observe the cardioprotective effects of increased endogenous epo, induced after normobaric oxygen breathing.

currently, renal tissue hypoxia is the only widely accepted trigger for erythropoietin (epo) production. however, previous studies in healthy subjects have demonstrated that a sudden and sustained decrease in tissue oxygen level, aside from an absolute low level of tissue oxygen tension, could also act as a trigger for epo production. to confirm these observations and to clarify an eventual role of free oxygen radicals and antioxidants, hypobaric pure oxygen will be administered to healthy subjects. the major physiologic function of epo is thought to be the induction of erythropoiesis. however, a growing body of evidence indicates that epo has tissue-protective effects and prevents tissue damage during ischemia. in an ex vivo proof-of-concept, protective effects of epo have been shown in human myocardium. the second goal of our study is to observe the cardioprotective effects of increased endogenous epo, induced after normobaric oxygen breathing.

Eligibility criteria:
inclusion criteria: * healthy non-smokers; patients undergoing cabg under cardiopulmonary bypass exclusion criteria: * subjects with a pulmonary disease; subjects who have stayed at high altitude since at least 3 months; healthy subjects taking medication; patients undergoing a redo or combined cardiac surgery; patients with renal insufficiency; any emergency cabg; patients with pulmonary disease

Keywords: healthy subjects cabg patients undergoing coronary artery bypass graft under cardiopulmonary bypass
effect of different modalities of cryotherapy on post-operative pain in patients with symptomatic irreversible pulpitis

Conditions: Endodontic Disease; Endodontically Treated Teeth

Summary: problem statement: the post-operative pain after endodontic treatment. aim of study: the study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (smc) versus intra-canal cryotherapy (icc) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (sap). the material and methods: subjects and methods: sixty patients will be randomly divided into three groups: the smc group, the icc group, and the control group. the patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. quantification of substance p will be done using an elisa test from peri-radicular fluid swab.


Eligibility criteria:
inclusion criteria: * older than age of 18 years * participants willing to commit for the entire period of the trial and both genders * agreed to sign the written consent after full explanation of the study * having a mandibular single rooted premolar tooth with vital pulp * these patients were also suffering from symptoms of symptomatic irreversible pulpitis and apical periodontitis, intermittent or continuous sharp pain that lasts longer after removal of the stimulus. on the basis of the clinical symptoms of severe preoperative pain (visual analogue scale) exclusion criteria: * vulnerable group; prisoners, pregnant females, mentally ill, etc... * teeth with open apices * a previous root canal treatment * sinus tracts * presence of periodontal pockets \>3 mm in the affected tooth